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Brasseler U.S.A. Medical, LLC

USA · Savannah

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

15listed device types

Class I 9Class II 6Class III 0

plus 17 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class II 5

16 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States17 registration records, 1 510(k), 0 PMA, 4 excluded

Brazil3 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada5 confirmed, 2 excluded

Manufacturer names merged into this page: Brasseler U.S.A. Medical, LLC · PETER BRASSELER HOLDINGS, LLC ALSO TRADING AS BRASSELER U.S.A. MEDICAL, LLC · BRASSELER USA, MEDICAL L.L.C. · BRASSELER USA MEDICAL, L.L.C

FDA 510(k) clearances by year

11988 · K883255

FDA listed device types

showing 8 of 15

Pin, Fixation, Smooth 1Wrap, Sterilization 1Pin, Fixation, Threaded 1System, Cement Removal Extraction 1Drills, Burrs, Trephines & Accessories (Simple, Powered) 1Lavage, Jet 1Instrument, Cast Removal, Ac-Powered 1Saw, Pneumatically Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K883255	KOMET SURGICAL BUR	1988-09-15
BR	80978569061	Lâminas de serra descartáveis	Class II
BR	80597740007	BROCA CIRÚRGICA	Class II
BR	80597740008	BROCA DIAMANTADA	Class II
CA	64510	BSPRAZR 100 HIGH SPEED DRILL SYSTEM	Class II
CA	71752	BSPMAX ORTHOPAEDIC POWER SYSTEM	Class II
CA	71754	PNEUMICRO SMALL BONE POWER SYSTEM	Class II

Brasseler U.S.A. Medical, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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